MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE XL; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 50-501XL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Device identifier: (b)(4).D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.3 devices were involved in this case: 1222780-2024-00093, 1222780-2024-00094 and 1222780-2024-00095.

Event Description

It was reported that on (b)(6) a myosure procedure was performed and during the procedure, the doctor was resecting a calcified fibroid and had used 2 xl devices that had both become dull from cutting and was opening a 3rd device to continue removal.The doctor plugged in the 3rd device and began to continue the resection.The doctor was applying some pressure/torque to the device to keep cutting the fibroid.There was an audible change in sound, then the vibration stopped, then the machine stopped.During resection with the 3rd device, the screen on the myosure control unit went black and the device stopped.The doctor removed the device and staff power cycled the control unit to continue the procedure.The doctor reintroduced the scope after the power cycle and visualized metal shavings in the cavity.The doctor then opened a myosure reach to try and remove the metal shavings from the cavity.It was removed as many shavings as possible and the doctor chose to abort the procedure as they were approaching the deficit limit.At this time, the patient is not being kept for further observation and was not provided with any additional medication or treatment.No additional information available.

• Brand Name: MYOSURE XL
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 18857082
• MDR Text Key: 337120277
• Report Number: 1222780-2024-00094
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: CUSTOMER UNABLE TO PROVIDE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female